A Study to Evaluate the Efficacy and Safety of DA-8010 in Patients With Overactive Bladder

  • STATUS
    Recruiting
  • End date
    Mar 19, 2024
  • participants needed
    595
  • sponsor
    Dong-A ST Co., Ltd.
Updated on 19 June 2022
solifenacin

Summary

This study will evaluate the efficacy and safety of DA-8010 in patients with overactive bladder.

Details
Condition Overactive Bladder
Treatment DA-8010 Placebo, DA-8010 2.5mg, DA-8010 5mg, Solifenacin 5mg, Solifenacin succinate placebo
Clinical Study IdentifierNCT05282069
SponsorDong-A ST Co., Ltd.
Last Modified on19 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Main Inclusion at Screening (Visit 1)
Men and women 19 years or older with OAB symptoms for ≥ 3 months
Subject who is willing and able to complete the voiding diary correctly
Subject who is willing and able to provide informed consent indicating that they understand the purpose and procedures required for the study

Exclusion Criteria

Main Exclusion at Screening (Visit 1)
Clinically significant stress urinary incontinence or mixed urinary incontinence where stress is the predominant factor
Subject who has Injury or neurodegenerative disease which is able to effect on lower urinary tract and nerves
Subject with diabetes insipidus, urinary stone, urinary tract infection, interstitial cystitis, recurrent urinary tract infection, pelvic organ prolapse or neurogenic bladder
Clinically significant benign prostatic hyperplasia at the discretion of the investigator
Had bladder or lower urinary tract surgery within 12 months from the screening visit
Medical history of malignant tumor in urinary system or pelvic organs
>150 mL of post-void residual volume in the screening test
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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